Efficacy And Safety Of Lurasidone Versus Lamotrigine As An Adjunct Therapy In Bipolar-II Depressio
Not Applicable
- Conditions
- Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity
- Registration Number
- CTRI/2022/01/039683
- Lead Sponsor
- Government medical college patiala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Male and female patients aged 18-65 years with patient fulfilling DSM 5 criteria for bipolar II depression.
2. Patients who will be medically stable .
3. Patients who have given written informed consent
Exclusion Criteria
1. Patients with history of epilepsy, mental retardation or any other organic disorder.
2. Pregnant women and lactating mothers.
3.History of seizures, renal insufficiency or congestive heart failure.
4.History of drug abuse and dependence in the last six months.
5. Refusal to give informed consent
6. History of hypesenstivity/rash/bronchial asthma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure will be early response to treatment by improvement in severity of depression on HRSD, response will be more than 50% improvement on Ham D, remissions score HRSD 7 ,improvement in impulsivity in BIS and improvement in sleep quality on PSQI and Clinical global improvement on CGI-BP scale. Alda scale measures improvement during course of treatment and score of more than 7 is for treatment response.Timepoint: Data will be collected at 0 weeks, 6 weeks , 8 weeks and 14 weeks
- Secondary Outcome Measures
Name Time Method Secondary outcome measures will be improvement in risk of suicidality on C-SSRS, adverse events on ADR and improvement in quality of life on SF-36.Timepoint: 0 week, 4 week , 8 week and 16 week